The present invention generally relates to data management for medical devices. Specifically, the invention relates to an apparatus and method for variably encrypting and transferring of data transmitted between various devices. More specifically, the invention provides for dynamic encryption of patient data, program commands, physician""s options and choices, and similar parameters at varying levels of security based on the content and nature of the data.
A network of devices having data communications capabilities, that are associated with implantable medical devices (IMDs) has been provided for the administration of IMDs. On the network may be implemented a system and method of bi-directional telecommunications between an expert data center, clinicians, and an IMD programmer device, utilizing various types of network platforms and architecture to implement, in the programmer, distance-based troubleshooting, maintenance, upgrade, information and is administrative services thereby providing an economical and highly interactive system for therapy and clinical care.
The assignee of the present invention has disclosed data management, transfer and archiving schemes relating to IMDs and associated instruments such as a programmer, remote monitor and similar instruments, which are in data communications with the IMDs. The structures and methods of these schemes are generally defined in applications entitled xe2x80x9cMedical System Having Improved Telemetry,xe2x80x9d filed Jul. 19, 1999, Ser. No. 09/356,340 now U.S. Pat. No. 6,298,271; xe2x80x9cSystem and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location,xe2x80x9d filed on Jul. 21, 1999, Ser. No. 09/358,081 now U.S. Pat. No. 6,250,309; xe2x80x9cApparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,xe2x80x9d filed on Oct. 26, 1999, Ser. No. 09/426,741 now U.S. Pat. No. 6,442,433; xe2x80x9cTactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,708; xe2x80x9cApparatus and Method for Automated Invoicing of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,208 now U.S. Pat. No. 6,385,593; xe2x80x9cApparatus and Method for Remote Self-Identification of Components in Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,956 now abandoned; xe2x80x9cApparatus and Method to Automate Remote Software Updates of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,960 now U.S. Pat. No. 6,363,282; xe2x80x9cMethod and Apparatus to Secure Data Transfer From Medical Device Systems,xe2x80x9d filed Nov. 2, 1999, Ser. No. 09/431,881 xe2x80x9cImplantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,xe2x80x9d filed Nov. 4, 1999, Ser. No. 09/433,477 now U.S. Pat. No. 6,411,851; xe2x80x9cRemote Delivery Of Software-Based Training For Implantable Medical Device Systems,xe2x80x9d filed Nov. 10, 1999, Ser. No. 09/437,615 now U.S. Pat. No. 6,386,882; xe2x80x9cApparatus and Method for Remote Therapy and Diagnosis in Medical Devices Via Interface Systems,xe2x80x9d filed Dec. 14, 1999, Ser. No. 09/460,580 now U.S. Pat. No. 6,418,436; xe2x80x9cVirtual Remote Monitor, Alert, Diagnostics and Programming For Implantable Medical Device Systemsxe2x80x9d filed Dec. 17, 1999, Ser. No. 09/466,284 now U.S. Pat. No. 6,497,655; xe2x80x9cInstrumentation and Software for Remote Monitoring and Programming of Implantable Medical Devices (IMDs), filed Dec. 21, 1999, Ser. No. 60/172,937; xe2x80x9cApplication Proxy For Telecommunication-enabled Remote Medical Access Instruments,xe2x80x9d filed Dec. 23, 1999, Ser. No. 60/173,081; xe2x80x9cInformation Network Scheme For Interrogation Of Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,064; xe2x80x9cMedical Device GUI For Cardiac Electrophysiology Display And Data Communications,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,065; xe2x80x9cIntegrated Software System For Implantable Medical Device Installation And Management,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,082; xe2x80x9cDynamic Bandwidth Monitor And Adjuster For Remote Communications With A Medical Device,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,083 xe2x80x9cLarge-Scale Processing Loop For Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,079; xe2x80x9cChronic Real-Time Information Management Systems For Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,062; xe2x80x9cAutomatic Voice and Data Recognition For Medical Device Instrument Systems,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,071 xe2x80x9cCentral Switchboard to Facilitate Remote Collaboration With Medical Instruments,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,080; xe2x80x9cSystem Of Notification Of Recalled Components For A Medical Devicexe2x80x9d filed Dec. 29, 1999, Ser. No. 09/474,694; xe2x80x9cA Communications System For An Implantable Device And A Drug Dispenserxe2x80x9d Dec. 30, 1999, Ser. No. 09/475,709 now U.S. Pat. No. 6,471,645; xe2x80x9cUser Authentication In Medical Systems Device,xe2x80x9d filed Dec. 30, 1999, Ser. No. 60/173,822; xe2x80x9cAutomated Invoicing Based On Medical System Usage,xe2x80x9d filed Dec. 30, 1999, Ser. No. 60/173,824; xe2x80x9cResponsive Manufacturing and Inventory Control,xe2x80x9d filed Feb. 4, 2000, Ser. No. 60/180,289; xe2x80x9cInformation Remote Monitor (IRM) Medical Device,xe2x80x9d filed Feb. 4, 2000, Ser. No. 60/180,285 xe2x80x9cFollow-Up Monitor For Implantable Medical Device,xe2x80x9d filed Feb. 23, 2000, Ser. No. 60/184,221; xe2x80x9cImplantable Medical Device With Multi-Vector Sensing Electrodes,xe2x80x9d filed Mar. 1, 2000, Ser. No. 60/186,235; xe2x80x9cStimulator For Delivery Of Molecular Therapy,xe2x80x9d filed Mar, 7, 2000, Ser. No. 60/187,280; xe2x80x9cIndividualized, Integrated, And Informative Internet Portal For Holistic Management of Patients With Implantable Devices,xe2x80x9d filed Mar. 15, 2000, Ser. No. 60/189,562; xe2x80x9cHeart Failure Monitor Quick Look Summary For Patient Management Systems,xe2x80x9d filed Mar. 17, 2000, Ser. No. 60/190,272; xe2x80x9cA Universal Interface For Medical Device Data Management,xe2x80x9d filed Mar. 17, 2000, Ser. No. 60/190,465; xe2x80x9cTelepresence Apparatus And Method For Remote Implantable Medical Device Implementation And Management,xe2x80x9d filed Mar. 24, 2000, Ser. No. 60/192,006; xe2x80x9cA Hand-Held Surface ECG and RF Apparatus Incorporated With a Medical Device,xe2x80x9d filed Mar. 29, 2000, Ser. No. 60/192,943,; all of which are incorporated herein by reference in their entirety.
Data encryption is a valuable tool for protecting privacy and ensuring data authenticity. Specifically, encryption technology which has wide application in the management of regulated therapy and diagnosis data, is widely used. More particularly, security relating to medical data is important to prevent tampering, modification or data corruption when data is sent over a public network that is potentially subject to eavesdropping and tampering. Even for dedicated lines and other secure data channels, it may be desirable to use encryption technology, such as digital signatures or checksums to ensure the integrity of transmitted messages. Such confirmation by means of digital signatures or checksums may be particularly indicated in patient care, where privacy, accuracy in instructions, either to a human caregiver or to a remote device, may be important. For example, the highest level of security and accuracy may be indicated for patient data on which critical therapy and diagnosis depend. On the other side of the security spectrum, data that is collected by a sensor on a real time basis, for example, an Electrocardiogram (ECG), an electroencephalogram, or an IEGM, may be sent with minimal or no protection and relatively lower accuracy. In addition, the reduction in computing overhead to which real-time data may be subject according to an embodiment of the present invention helps to ensure that no distortion of data, as a function of time, is injected into the real-time physiologic data being transmitted.
Prior art encryption systems are not dynamically adjustable. Further, prior art systems lack selectable encryption devices and methods which are based on the level of security assigned to the data to be encrypted. Additionally, various networks such as the Internet, World Wide Web, and the like do not implement dynamically variable encryption systems. Prior art systems or networks typically implement encryption on a highly granular level. Typically, these prior art systems will either encrypt all of the systems data at either a very high level, an intermediate level, or not at all. There are problems associated with each one of these levels. If one chooses to encrypt all their data with a high encryption level, then the data will be very secure, however, a large amount of bandwidth is needed to transmit the information. If one chooses to encrypt all of their data at an intermediate level, then the amount of bandwidth required decreases, however, the security of the information decreases. Moreover, if no encryption is utilized, then the amount of bandwidth needed is at a minimum, however the information is not secure.
The present invention provides for an encryption apparatus and method in which data from an Implantable Medical Device (xe2x80x9cIMDxe2x80x9d) and a data center could be transferred based on a differentiated encryption system. The encryption scheme allows for the differentiation, segregation, and classification of data at required or needed levels of security. The present invention relates to an apparatus and method for securely transferring sensitive information, such as patient information, between a programmer and a clinician computer using encryption methods and structure implemented in hardware or software systems to protect the data from eavesdropping, and ensure its authenticity and integrity. Therefore, one aspect of the present invention to provide a method and apparatus to variably encrypt and transfer data sent between various elements of a data system. Another aspect of the present invention is differentiating between data requiring a high level of encryption from data requiring low or no data encryption.
Yet another aspect of the present invention is to provide a high level of encryption to sensitive data to prevent unauthorized use and or modification.
A further aspect of the present invention is to provide a method and apparatus to variably encrypt and transfer data sent between various elements of a data system through various public networks or internetworks such as the Internet.
Another aspect of the present invention is to provide an apparatus and method, which utilizes bandwidth more efficiently by differentiating between different types of data and only encrypting the data when necessary. Before transfer of the data, either from an IMD or any other part of a support network for the IMDs, the encryption device begins to distinguish the data. In an alternate embodiment of the present invention, the encryption scheme may be manually selected according to the preferences of a user, such as a patient. The variable data is then classified based on various levels of security having distinct encryption protocols. After classification the data is encrypted based on the data""s level of security. The data is then transmitted. Upon being received the data is then segregated based on whether the data is encrypted. The encrypted data is then decrypted and may be interpreted by a human clinician or forwarded to a analytical system, computer, or medical device.